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Inpatient Facililty DiagnosesNCT03697915

Implementing Lift System for Early Mobilization

A study testing Experimental in people with Inpatient Facililty Diagnoses, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Inpatient Facililty Diagnoses
What is being tested?
Experimental
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Jun 2018to 8 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • undergone surgical procedures leading to immobilisation
  • having a disease affecting the musculoskeletal system
  • being conscious and not having sitting balance.

Who cannot join

  • co-operation, orientation
  • cognitive impairment.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tomri̇s Duymaz

    Istanbul, 34440

Other trials in Turkey (Türkiye)

About this study

Official title: Implementing Lift System to Physical Therapy Program for Early Mobilization in Immobilised Patients: A Randomised Controlled Trial

Objective:Immobilization causes various physiological and biomechanical problems during inpatient treatments.Physical therapy is applied to achieve early mobilization and avoid complication of immobilization.

Aim:The aim of this study is to assess the contribution of using lift system to physical therapy program of immobilized patients.

Read more

Design:A randomised controlled trial. Patients:Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups.

Interventions: Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.Patients allocated to the add-on lift system were held in upright position with James lift® system during each physical therapy(PT).Patients allocated to PT program only were upgraded to a therapeutic goal of stability during standing phase as the patient's muscular strength improved.

Read the detailed description

In this study, 30 patients aged 50-75 years who were immobilised for >1 week and were conscious but did not have sitting balance were evaluated. Before this study was initiated, approval was obtained from the XXX University Ethics Committee (number 2018-40016-46, dated 24/04/2018). The inclusion criteria for the study included having undergone surgical procedures leading to immobilisation or having a disease affecting the musculoskeletal system, being conscious and not having sitting balance. The exclusion criteria included co-operation, orientation and cognitive impairment.

Patients were divided into two groups: control group, in which a conventional physical therapy programme was applied, and experimental group, in which a physical therapy programme supplemented by the James lift system was applied. Randomisation was performed according to the hospitalisation order of the patients.

Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.

In addition to the conventional treatment programme in the experimental group, orthostatic blood pressure was checked at the early stage before the patients gained sitting balance. Once the patients gained standing balance using the lift, they were administered walking training.

Conventional physical therapy was administered to both the groups and included passive and active assisted joint range of motion exercises, sitting balance, standing balance, electrotherapy (20 min of electrical stimulation on bilateral quadriceps and muscles) and ambulatory training.

Pre- and post-treatment evaluations included age, height, weight, duration of hospital stay and day of initial mobilisation. Clinical and Rivermead mobility indices were used as the primary outcome. The Barthel index, which assesses daily living activities, and hospitalisation period were evaluated as secondary outcomes.

The James 150 lift system is a hydraulic system made of steel pipes with a carrying capacity of 150 kg and is designed to keep the patients in an upright position. It is a hydraulic transport system with a short installation time, including an electric lift arm, 24-Volt motor, wired remote control, emergency button, mechanical emergency lowering, extensible undercarriage pedal, swivel castors and rear-wheel brakes. When a patient is required to be switched to the upright position, he/she is supported by Velcro sheaths in the thoracolumbar area, knees are locked with knee supports, feet are switched to the dorsiflex position using the foot pedal and the patient is brought to the upright position. During this time, the patient grips the lift handles with his/her hands for support. The patient is protected against falling during the lifting process by the brake-lock system.

The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility.

The clinical mobility scale evaluates the level of mobility and is scored between 0 and 3 points. It includes the following items: upright posture, walking, gait, sitting, stair climbing, hand-held appliances and wheelchair and time usage. It is scored between 0 and 24 points, and higher scores indicate increased mobility.

The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient.

Being tested
Experimental
Keywords
Lift system, Early mobilization, Immobilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalDevice

    Also called Control

    Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.

Study groups in NCT03697915
Study groupRoleWhat they receive
Experimental groupExperimentalExperimental group, in which a physical therapy programme supplemented by the James lift system was applied
Receives: Device: Experimental
ControlPlacebo comparatorControl group, in which a conventional physical therapy programme was applied.
Receives: Device: Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mobility index

    The Rivermead mobility index reflects basic mobility activities. The questionnaire consists of 15 questions, of which 14 are self-reported items and one is a direct observation item. "Yes" answers are given 1 point. The index is scored between 0 and 15 points, where 15 indicate normal mobility, whereas ≤14 indicate impaired mobility

    Measured: 1 minute

Secondary outcomes (1)
  1. Daily life activities

    The Barthel index scores daily life activities. The total score can range between 0 and 100 points, with each question score ranging from 0.5 to 10 points. The sub-topics covered include feeding, bathing, grooming, dressing, bowel care, bladder care, toilet use, transfer (bed to chair and back), mobility (on levelled surfaces) and stair climbing. Higher scores indicate improved independence of the patient

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start2 Jun 2018
  3. Primary completion25 Sep 2018
  4. Study completion8 Oct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Thirty hospitalized patients who were immobile more than 1 week were randomised into two groups. Each group had received 15 sessions of physical therapy (ROM exercises and electrotherapy) regularly.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697915
Sponsor's protocol ID
2018-40016-46
Other IDs
2018
Status last verified
Oct 2018
First submitted
4 Oct 2018
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Inpatient Facililty Diagnoses, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mobility index (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.

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